the ctsi and the va: opportunities for discovery mike conlon, phd associate director, uf ctsi...
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The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
The CTSI and the VA:Opportunities for Discovery
Mike Conlon, PhDAssociate Director, UF CTSI
Presented at VA Research Inspires!Gainesville, Florida
May 15, 2013
National Institutes of Health Clinical and Translational Science Awards
• In 2006, NIH developed the Clinical and Translational Science Award (CTSA) Program
• The CTSA consortium vision:• to improve human health by transforming the research and training
environment to enhance the efficacy and quality of clinical and translational research
• National Strategic Goals:• National Clinical and Translational Research Capacity• T1 Translational Research• The Training and Career Development of Clinical and Translational Scientists• Consortium-Wide Collaborations• The Health of our Communities and Nation
• The 61 CTSA institutions are linked together to transform the local, regional, and national environment to increase the efficiency and speed of clinical and translational research
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Clinical and Translational Science Award Consortium
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
The Four Translations
Population Health/
Scientific Discovery
Human ApplicationsTherapies
Practice
T1 – Translation to humans. Scientific discoveries applied to human health. E.g. Genetics, engineering
T2 – Translation to patients. Demonstrate use is safe and effective. E.g. Clinical Trials
T3 – Translation to practice. How to increase uptake of new approaches. E.g. Clinical Outcomes, Health Services Research
T4 – Translation to population health. Studies outside care settings E.g. Weight loss, access to care, behavioral studies
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR00065 and TL1 TR000066
Services and Resources
• Biostatistics• Education Programs• Population Science• Laboratory Science• Clinical Science• Funding Programs• Informatics• Data Services• And More
In 2012, more than 900 UF investigators received services from the CTSI.Note: Many services are provided at no-cost to investigators. Other services have charges associated. Please contact service providers regarding their charges, if any.
Research Design and Analysis
• Overarching goal– Consult, collaborate, conduct research, and educate
on study design and biostatistical issues in CTS• Activities
– Study Design – clinical trials, observational studies, cohort, chart review, qualitative, epidemiologic
– Power Analysis– Data Analysis– Data presentation and visualization– Qualitative research collaborations– Survey design– Data Coordinating Center Services– Study Design Lunch Series
Jon Shuster, PhD
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Translational Technologies and Resources Program
• Overarching Goal– Develop and Provide basic science tools and
services for research• Services
– CTSI Biorepository (M. Clare-Salzer)– Genotyping (J. Johnson)– Biobehavioral (S. Nixon)– Human Imaging (S. Lai)– Biomedical Mass Spectrometry (T. Garrett)– Global Metabolomics (D. Powell)– Quality Assurance, GCP, GLP (C. Abernathy)– Simulation (S. Lampotang) Jesse Gregory, PhD
Michael Clare-Salzler, MD
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
CTSI Biorepository• Biospecimen collection, processing and
storage. Stored biospecimens can be used by any researcher with IRB-approved protocols.
• Prospective biospecimen collection to fulfill investigator needs for IRB-approved protocols.
• Storage for biospecimens collected by investigators. Stored biospecimens belong solely to the investigator.
• Oversight of the release of biospecimens from the UF Department of Pathology for other IRB-approved research protocols.
• Pathology services including those provided by the Molecular Pathology Core and confirmation of diagnosis by a board-certified pathologist upon request.
One of two Hamilton Storage Technologies’ SAM -80°C automated sample management systems (Robotic freezers). The biorepository also has eight Forma Thermo Scientific -80°C Freezers with back-up CO2 and sensaphone alarm systems including back-up storage space, centrifuge for basic bodily fluid processing, QiaCube for small volume RNA, DNA and protein purification, Agilent Bioanalyzer for RNA, DNA and protein quality control analysis, OnCore BioSpecimen Management
The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
Human Imaging Core• Structural and functional MRI• Methods and protocols for MRI data
acquisition• Image quality assurance and quality
control• Image acquisition and transfer
support• Image archive, review, and access• Teaching investigators data
acquisition and analysis techniques• Assisting researchers in designing
experimental protocols• Development of advanced MR
imaging and spectroscopy methodology
The centerpiece of the Core is a state-of-the-art 3.0 Tesla, 32-channel Philips whole-body human MRI scanner dedicated to research. The scanner is equipped with a series of coils for imaging human organ systems, including a 32-channel head coil for neuroimaging applications with significant gains in signal-to-noise ratio and acquisition speed. An ESys® system by Invivo is available for presenting video and audio signals including functional MRI task paradigms to the subjects during scanning.
CTSI REDCap Services• No-charge, unlimited self-service
access to REDCap and REDCap Survey
• Training in REDCap data entry and study set-up
• Support Services• Configuration Service
Participation in the national consortium• Augmented REDCap to use
standard sign-on methods (GatorLink)
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Informatics
• Clinical and Translational Science IT (Felix Liu, PhD)– Software development– Web site design– Database design– Equipment interfaces– Hosting and application support (60 systems
including REDCap, Health IMPACTS, CTSI Portal, Personalized Medicine, Study Registry, investigator systems)
• Collaborate with– Academic Health Center IT (Kari Cassel)– Integrated Data Repository (Gigi Lipori)– UF Research Computing (Paul Avery, Erik Deumens)– Investigative groups across UF and beyond
CTS IT
CTSI
UF Research
Computing
IDR
UF AHC IT
Integrated Data Repository
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Clinical and Translational Research Buildings
Clinical and Translational Research Building (CTRB)- CTSI, Institute on Aging,
Biostatistics, Epidemiology, Health Outcomes & Policy
- 120,000 ft2 total- 20,000 ft2 patient research- Opens April 2013
Lake Nona-Orlando- CTSI, Institute on Aging, COM,
Pharmacy- Clinical research unit- Community engagement
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
The UF Clinical Research Center
Opening June, 2013
10 exam rooms, 3 overnight stay rooms, infusion suite, pediatric and adult waiting rooms, Muscular Dystrophy, Pain and Physiology assessment labs, Investigational Pharmacy,
Metabolic Kitchen (3rd floor), Sample Processing Laboratory. 10,437 ft2.
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Community Engagement and Research
Overarching GoalTo promote collaborative relationships with communities to address the health and well-being of community members
Elizabeth Shenkman, PhD Mobeen Rathore, MD Linda Cottler, PhD
Resources- Community Advisory Boards- Community Research
Associates- HealthStreet- Health Impacts- Research Networks
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Assessment: Assess health issues and concerns from community residentsEducation: Provide informational materials and resources tailored to health promotion, wellness and dissemination of new research knowledge for community stakeholdersService: Link individuals who have been underrepresented in services and research to social services, health care and research opportunitiesCommunication: The HealthStreet site will serve as an anchor for community groups and investigators to engage in bidirectional, health-focused communications with the goal of increasing community engaged research partnerships
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
Goals• Test interventions in physician
practices; • Translate research findings into
improved health care quality; and • Mentor medical students and trainees
in conducting research and implementing research findings in practice.
Two pilot projects• Sports related concussion surveillance
and management (PI: Bauer)• Health risk assessment among
adolescents in primary care (PI: Shenkman)
Funding• UF/FSU ($500,000)• State of Florida ($600,000)• NIH ($ 473,000)
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
UF-Affiliated Research Networks
• Local/ Regional– North Florida Pediatric Community Research Network (Jacksonville area)– Jacksonville Health Equity Research Organization Practice-Based Research
Network (JaxHERO) • Statewide
– Health IMPACTS for Florida (UF-FSU statewide research network)– Florida Neonatal Neurologic Network
• National– NHLBI Cardiovascular Cell Therapy Research Network (Carl Pepine)– NIDCR Dental Practice-Based Research Network (Valeria Gordan)– Hepatitis C Therapeutic Registry and Research Network (David Nelson)– Network for Pancreatic Organ Donors with Diabetes (Mark Atkinson)– NIH Pharmacogenomics Research Network (Julie Johnson)– Sentinel Network for Community-Based Participatory Research (Linda Cottler)
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066
For More Information
• On the web– www.ctsi.ufl.edu
• Call– 352-273-8700
• Email– [email protected]
The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR000065 and TL1 TR000066